Blood processing apparatus such as extracorporeal blood treatment machines comprise a number of components which have a use limited in time or in the number of use cycles. In the present specification, the following definitions assume the meaning below indicated:                disposables are those components which can be associate to the processing apparatus for the duration of a single procedure or treatment (i.e. single use components)        semi-disposables are those components which can be associate to the processing apparatus for the duration of a limited number of procedures or treatments (i.e. components designed to be used a limited number of times).        
Depending upon the situations, components such as filters (hemo-dialyzers, hemo-filters, ultrafilters and the like), solutions bags, containers hosting liquids or powders for preparation of treatment liquids, tubing sets, extracorporeal blood circuits, integrated modules including a number of the components just mentioned could be used as disposables or semi-disposables.
Before the medical apparatus, e.g. a blood treatment machine, has to execute a treatment session, the operator shall setup the machine and install all appropriate disposable components suitable for running the selected treatment procedure. The operator also checks if one or more semi-disposable components need to be changed.
Referring for instance to a blood treatment for treating patients suffering from kidney failure, before any procedure starts the operator should normally install the filter, the bloodlines, the access devices adequate for the treatment session. The operator also installs the appropriate concentrates and solutions to be used during the treatment, checks and/or changes the ultrafilters in the liquid preparation circuit (in case on-line liquid preparation is selected).
For the purpose of disclosure of the present invention disposables and semi-disposable components are hereinafter globally referred to as replaceable components.
As it can be easily understood the blood treatment apparatus shall be properly instructed as to which specific replaceable components are installed because each component has specific properties which may affect the working of the apparatus and the direct or indirect delivery to the patient of substances.
During the past years, in order to facilitate setup procedures, those replaceable components to be mounted on the treatment apparatus have been provided with indicia (such as bar codes, color codes, microchips, RFID devices, mechanical keys, etcetera) secured to the component and detectable by a respective appropriate reader associated to the treatment apparatus to provide the apparatus at least with an information relating to the identity of the same component.
Here below the technical solutions which the applicant regards as relevant are described.
A first solution is disclosed in WO80-02376 which describes a hemodialysis system using disposables tubing and filter having optical or magnetic coding indicia on a strip. The strip can be coded to match a specific program or procedure, and the system can be constructed or programmed to generate a signal should the module and the program in the system not correspond.
U.S. Pat. No. 5,769,811 shows a blood processing machine and disposable units for use therewith. The disposable units generally comprise a centrifuge bowl for separating whole blood into blood constituents, an inlet tube for conveying blood into the bowl, an outlet tube for conveying the blood constituents away from the bowl, and a manifold for placing the inlet tube and the outlet tube in fluid communication with a tube from a donor. The manifold has a machine-readable bar-code label for identifying to the blood processing machine which type of disposable unit is being coupled to it. The machine itself comprises a central processing unit that controls overall operation, a first computer memory containing safety-monitoring instructions that cause the central processing unit to monitor various state parameters in order to ensure donor safety, and a second computer memory containing instructions that define at least one apheresis or blood-processing protocol. In some implementations, the second computer memory is removable from and insertable into the blood processing machine by an operator.
U.S. Pat. No. 6,626,355 discloses a medical apparatus comprising an accessory port and at least one accessory piece comprising a connection element complementary to said accessory port; the connection element includes a storage unit where coded and/or un-coded information is stored, is read by means of a readout unit disposed in the section of said accessory port, and is compared to identification information stored in readout unit; the medical device is activated when the identification information match the desired identification information, and is blocked when the identification information do not match. Coded identification information is de-codable by means of a proprietary key.
EP1170023 concerns a hemodialysis machine comprising at least one semi-permanent component, such as an ultrafilter for use in the online preparation of dialysis liquid. The component is changed periodically after being used for several consecutive dialysis treatments; the machine comprises a bar-code reader for identifying the semi-permanent components thus unequivocally identifying the semi-permanent component mounted on the machine, and communicating its presence and identity to said control unit in the machine.
U.S. Pat. No. 6,685,831 discloses a dialysis machine with a device for preparing dialysis solutions. Preparation of dialysis fluids of different concentrations is achieved by the fact that the device has a detector device, at least two connections and at least two interchangeable storage containers to hold the solution ingredients to be metered. Each container is connected to at least one connector, and the connectors are connectable to the connections; the connectors or the areas of a connecting tube near the connectors have identification means which can be detected by the detector device. It is also disclosed a connector for connecting a storage container with solution ingredients to a medical apparatus, where the connector or areas of a connecting tube near the connector has identification means. Detecting a connection of a solution ingredient storage container is guaranteed by the fact that the connector is provided with identification means and is attached to a matching component, and a reader unit determines the type and position of the connector.
WO01/41831 discloses a hemofiltration machine including a chassis, at least one flow controlling element on the chassis, and a controller for the hemofiltration machine to operate the flow controlling element to carry out a processing task in response to a control program, the controller including an input on the chassis for reading coded indicia, an extracorporeal circuit for circulating blood from an individual through a hemofilter, and a fluid processing cartridge holding the extracorporeal circuit for mounting as an integrated unit on the chassis in operating engagement with the flow controlling element and for removal as an integrated unit from the chassis, the fluid processing cartridge carrying coded indicia incorporating a control program for the controller, the coded indicia being readable by the input in response to mounting the fluid processing cartridge on the chassis, to thereby transfer the control program to the controller for execution. Document WO2004033024 shows a medical-technical identification device for identifying a sterile product for example a product intended for one-time-use only, when connected to a piece of medical equipment. The sterile product includes a fixedly mounted information carrier which is adapted to deliver or to offer specific product information in a contactless fashion to a reading element connected to the equipment.
U.S. Pat. No. 5,658,456 describes a dialysis apparatus having a dialysate preparation module and a tank for storing a dialysate solution, for performing automatic verification of dialysate chemicals prior to adding said chemicals to said dialysate preparation module so as to insure correct preparation of said dialysate solution, comprising: an electronic reader of a machine-readable indicator, said electronic reader incorporated into said dialysis machine; a bottle containing a unit batch of dialysate chemicals for treatment of a medical condition of a patient to be treated by said dialysis machine, said bottle adapted to be installed on an opening apparatus in said machine such that, when said bottle is opened, said dialysate chemicals are placed in fluid communication with said tank for delivery of said unit batch of dialysate chemicals automatically into said tank; and a machine-readable indicator containing coded information (ID,LOT,DATE) as to said dialysate chemicals contained in said bottle, said machine-readable indicator applied to said bottle in a manner for permitting machine identification of the contents of said bottle by said electronic reader prior to operating the opening apparatus to open said bottle and adding said dialysate chemicals to said tank, whereby machine identification of said dialysate chemicals contained in said bottle may occur prior to introduction of said chemicals into said tank.